T-trionimax

INSTRUCTIONS for medical use of the medicinal product T-TRIOMAX (T-TRIOMAX)

Composition:

Active substance: morpholine salt of thiatic acid;

1 ml of solution contains 25 mg of morpholine salt of thiatic acid;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical characteristics: clear colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Cardiological preparations. Other cardiological preparations. Thiatic acid. ATC code C01EB23.

Pharmacological properties.

Pharmacodynamics.

The active substance of the medicinal product exerts anti-ischemic, membrane-stabilizing, antioxidant, and immunomodulatory effects.

The mechanism of action of the medicinal product is associated with enhanced compensatory activation of anaerobic glycolysis and activation of oxidation processes in the Krebs cycle, thereby preserving the intracellular ATP pool.

The presence in the molecular structure of the morpholine salt of thiotropic acid of a thiol sulfur group, which possesses redox properties, and a tertiary nitrogen capable of binding excess hydrogen ions, promotes activation of the antioxidant system. The strong reducing properties of the thiol group lead to reactions with active oxygen species and lipid radicals, while reactivation of antiradical enzymes—superoxide dismutase, catalase, and glutathione peroxidase—prevents the initiation of active oxygen forms.

Improvement of blood rheological properties occurs due to activation of the fibrinolytic system.

The effect of the medicinal product results in inhibition of lipid peroxidation in ischemic areas of the myocardium, reduced myocardial sensitivity to catecholamines, prevention of progressive suppression of cardiac contractile function, and stabilization with a corresponding reduction in the area of myocardial necrosis and ischemia.

Improved myocardial metabolic processes, increased myocardial contractility, and support of cardiac rhythm normalization make it possible to recommend the medicinal product for the treatment of patients with various forms of ischemic heart disease.

In addition to its use in cardiology, the medicinal product can be used in the treatment of liver and other internal organ diseases, taking into account its pronounced hepatoprotective properties. The morpholine salt of thiotropic acid prevents hepatocyte destruction, reduces the degree of fatty infiltration and the spread of centrilobular liver necroses, promotes reparative regeneration of hepatocytes, and normalizes protein, carbohydrate, lipid, and pigment metabolism within them. It also increases the rate of bile synthesis and excretion and normalizes its chemical composition.

Pharmacokinetics.

After intramuscular administration, maximum plasma concentration of the morpholine salt of thiotropic acid is reached within 0.84 hours; after intravenous administration, within 0.1 hours. Plasma protein binding does not exceed 10%. The substance accumulates predominantly in the kidneys (31%), and to a significant extent also in the large intestine, heart, and spleen; the lowest concentrations are found in the small intestine and lungs (1–2%).

Clinical characteristics.

Indications.

In complex treatment of ischemic heart disease: angina pectoris, myocardial infarction, postinfarction cardiosclerosis.

As an additional agent in the therapy of cardiac arrhythmias.

In complex treatment of chronic hepatitis, alcoholic hepatitis, liver fibrosis, and cirrhosis.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Acute renal failure.

Pregnancy or breastfeeding period.

Pediatric age (under 18 years).

Interaction with other medicinal products and other forms of interaction.

As a cardio- and hepatoprotective medicinal product, it may be used in combination with basic therapy agents for ischemic heart disease and may be combined with conventional treatment methods for hepatitis of corresponding etiology.

Special precautions.

Use during pregnancy or breastfeeding.

There is insufficient experience with the use of the medicinal product during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Caution should be exercised when driving vehicles or operating other complex machinery in case of adverse reactions affecting the central or peripheral nervous system.

Dosage and Administration

In myocardial infarction and unstable angina: administer the drug intravenously slowly at a rate of 2 mL/min, injecting 4 mL of a 25 mg/mL solution (100 mg); or administer by intravenous infusion at a rate of 20–30 drops per minute (dilute 4 mL of a 25 mg/mL solution in 150–250 mL of 0.9% sodium chloride solution); or administer intramuscularly 4 mL of a 25 mg/mL solution (100 mg) 2–3 times daily. Treatment duration: 14 days.

In angina at rest and post-infarction cardiosclerosis: administer the drug intramuscularly, 2 mL of a 25 mg/mL solution, 3 times daily. Treatment duration: 20–30 days.

In effort angina: administer the drug intramuscularly, 4 mL of a 25 mg/mL solution, twice daily (daily dose: 200 mg). Treatment duration: 14 days.

In chronic hepatitis with marked disease activity: during the first 5 days, administer the drug intramuscularly, 2 mL of a 25 mg/mL solution (50 mg) 2–3 times daily; or intravenously slowly at a rate of 2 mL/minute, 4 mL of a 25 mg/mL solution (100 mg) once daily; or by intravenous infusion at a rate of 20–30 drops per minute (dilute 2 ampoules of a 25 mg/mL solution in 150–250 mL of 0.9% sodium chloride solution). From day 5 to day 20 of therapy, administer the drug in tablet form (100 mg three times daily).

In chronic hepatitis of minimal to moderate activity: administer the drug intramuscularly, 2 mL of a 25 mg/mL solution, 3 times daily. Treatment duration: 20–30 days.

In liver cirrhosis: initiate treatment with intramuscular administration of 2 mL of a 25 mg/mL solution (50 mg) 3 times daily for 5 days, followed by continuation of treatment with tablets (100 mg three times daily). Treatment duration: 60 days.

Children

There is insufficient experience with the use of the drug in children.

Overdose

Symptoms: increased concentrations of sodium and potassium in urine.

Treatment: discontinue the drug, symptomatic therapy.

Adverse reactions.

The medicinal product is usually well tolerated.

In patients with increased individual sensitivity, the following may occur:

Skin and subcutaneous tissue disorders: pruritus, skin hyperemia, rash, cases of urticaria;

Immune system disorders: hypersensitivity reactions have been reported with the use of other medicinal products, including angioneurotic edema and anaphylactic shock;

General disorders and administration site reactions: hot flushes, chills, and injection site reactions.

In predominantly elderly patients taking other medicinal products, the following may occur:

Nervous system disorders: general weakness, dizziness, tinnitus, headache;

Cardiovascular system disorders: tachycardia, arterial hypertension, cases of decreased blood pressure;

Gastrointestinal disorders: dyspeptic symptoms, including dry mouth, nausea, abdominal distension, vomiting;

Respiratory, thoracic and mediastinal disorders: dyspnea, asthma.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

2 ml or 4 ml in an ampoule; 5 ampoules in a blister pack; 2 blister packs in a carton.

Prescription status. Prescription only.

Manufacturer: JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and location of its business activity:

13, Boryspilska Street, Kyiv, 02093, Ukraine.